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CLINICAL CHEMISTRY 1 > PRELIM LEC: Quality Assurance (TRANSES) > Flashcards

PRELIM LEC: Quality Assurance (TRANSES) Flashcards

TRANSES AND NOTES

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1
Q

Overall program that ensures that the final
results reported by the laboratory are correct

A

Quality Assurance

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2
Q

It is concerned with all factors that affect the test results from preanalytic, analytic and post-analytic phases

A

Quality Assurance

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3
Q

System of ensuring accuracy and precision in the lab

A

Quality Control

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4
Q

Process of ensuring that analytical results are correct

A

Quality Control

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5
Q

QC samples are measured periodically in the
same manner as clinical samples

A

Quality Control

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6
Q

Objectives of Quality Control:

A
  1. To check the stability of the machine
  2. To check the quality of the reagent
  3. To check for technical/clerical error
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7
Q

Types of Quality Control:

A

Intralab
Interlab

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7
Q

AKA Internal Quality Control

A

Intralab

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8
Q

Analyses of control samples
together with patient specimens

A

Intralab

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9
Q

Important in daily monitoring

A

Intralab

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10
Q

AKA External Quality Control

A

Interlab

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11
Q

Involves proficiency testing
programs

A

Interlab

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12
Q

Ex.: National External Quality
Assessment Scheme (NEQAS)

A

Interlab

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13
Q

Under RIPN

A

Interlab

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14
Q

Sends out specimen to labs to test, results are sent back, and results are compared

A

Interlab

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15
Q

Characteristics of an Ideal QC Material

A
  1. With known analyte concentrations
  2. Inexpensive and stable for long periods
  3. No communicable diseases
  4. No matrix effect
  5. Convenient packaging for easy dispensing and storage
  6. Resembles human sample
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16
Q

Maintain long-term accuracy of
methods

A

Interlab

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17
Q

TYPES OF REAGENTS

A
  1. Reagent Blank
  2. Standard
  3. Control
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18
Q

Value will tell the conc. of the
unknown

A

Standard

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18
Q

Reagent without any analyte
added

A

Reagent Blank

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19
Q

Most specific analytical solution

A

Standard

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20
Q

Only one analyte

A

Standard

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21
Q

Resembles patient sample

A

Control

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22
Q

Value will determine accuracy and
precision

A

Control

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23
Q

Many analyte

A

Control

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23
Q

Done on sick or ill individuals
Basis for treatment
More accurate, more expensive

A

Diagnostic Test

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24
Q

Done on apparently healthy
individuals
Not a basis for treatment
Less accurate, less expensive

A

Screening Test

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25
Q

QUALITY CONTROL PARAMETERS:

A

Validity

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26
Q

Refers to how well the test measures what it is supposed to measure.

A

Validity

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27
Q

It refers to the accuracy of the test, meaning how close the result is to its true value.

A

Validity

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28
Q

Refers to how well the test performs in use over time

A

Reliability

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29
Q

It refers to the precision of the test, meaning how close are the results of a test on repetition or how close the values are from one another.

A

Reliability

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30
Q

Indicating a person has the
disease when, in fact, he or she
does

A

True positive (TP)

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31
Q

Indicating a person does not have
the disease when, in fact, he or she
does

A

False negative (FN)

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31
Q

Indicating a person has the
disease when, in fact, he or she
does not

A

False positive (FP)

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32
Q

Indicating a person does not have
the disease when, in fact, he or she
does not

A

True negative
(TN)

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33
Q

Ability of test to detect the smallest amount of
analyte

A

SENSITIVITY

34
Q

Ability of test to identify correctly those who
have the disease (a) from all individuals with
the disease (a+c)

A

Diagnostic Sensitivity

35
Q

Diagnostic Sensitivity FORMULA:

A

[TP / (TP + FN)]

36
Q

Ability of test to detect substances without interferences

A

SPECIFICITY

37
Q

Ability of the test to identify correctly those
who do not have the disease (d) from all
individuals free from the disease (b+d)

A

Diagnostic Specificity

38
Q

Diagnostic Specificity FORMULA:

A

[TN / (TN + FP)]

39
Q

Middle value

A

Median

40
Q

Measure of central
tendency

A

Mean

41
Q

Most frequent value

A

Mode

42
Q

Index of precision

A

Coefficient of
Variation

42
Q

Highest value – lowest value

A

Range

43
Q

Measures of dispersion

A

Standard Deviation
and Variance

44
Q

Predictable errors; an error that is constant
when measurements are made under the
same conditions

A

SYSTEMATIC ERRORS

45
Q

SYSTEMATIC ERRORS 2 TYPES:

A

Constant error & Proportional error

46
Q

SYSTEMATIC ERRORS Causes:

A

deterioration of reagents, improperly
made standard solutions, contaminated
solutions, calibration problems, failing
instrumentation

47
Q

Unpredictable errors; often due to instrument,
operator, and environmental conditions

A

RANDOM ERRORS

48
Q

RANDOM ERRORS CAUSES:

A

pipetting error, mislabeling of samples, temperature fluctuation, improper
mixing of sample and reagent

48
Q

the most
commonly used histogram in QC

A

LEVEY-JENNINGS CHART

49
Q

A histogram is/are sheets of rectangular
coordinate graphing paper where data for
sequential analysis are plotted to locate the
source of error

A

LEVEY-JENNINGS CHART

50
Q

Results from QC fall within the
confidence limit

A

In Control

51
Q

The values of the control fall
outside the confidence limit

A

Out of Control

52
Q

Formed by the control that continue to
either increase or decrease for a period of 6 or more consecutive days

A

Trend

53
Q

Formed by the control that distribute
themselves on one side (above or below) of the mean, with no tendency toward either a
consistent fall or rise

A

Shift

54
Q

Values which are far from the main
set of values due to wild errors

A

Outlier/s

55
Q

is a “multi-rule” system

A

Wesguard Multirule System

56
Q

Developed by Dr. James O. Westgard

A

Wesguard Multirule System

57
Q

Based on statistical concepts which is a
combination of decision criteria or rules to
assess if a system is in control

A

Wesguard Multirule System

58
Q

Violated if the IQC value exceeds the mean by ±2SD

A

1 2s

59
Q

Violated when the IQC value exceeds the mean by
±3SD

A

1 3s

60
Q

Violated when two consecutive IQC values exceed the mean on the same side of the mean by ±2SD

A

2 2s

61
Q

Violated if four consecutive IQC values exceed the same limit (mean ± 1SD)

A

4 1s

61
Q

Violated when one control exceeding the +2s and
another exceeding the -2s

A

R 4s

62
Q

Violated when 10 consecutive IQC values are on the same side of the mean or target value

A

10x

63
Q

How close the measured value is to the true
value due to systematic error, which can be
either constant or proportional

A

Accuracy

64
Q

➔ AKA Linear or Dynamic Range
➔ Range of analyte concentrations that can be directly measured without dilution,
concentration, or other pretreatment

A

Analytic Measurement Range (AMR)

65
Q

➔ AKA Cross-reactivity
➔ Ability of a method to detect only the analyte it is designed to determine

A

Analytic Specificity

66
Q

Ability of a method to detect small quantities
or small changes in concentrations of an
analyte

A

Analytic Sensitivity

67
Q

Difference between the true value and the measured value

A

Bias

68
Q

Range of analyte that a method can
quantitatively report, allowing for dilution,
concentration, or other pretreatment used to
extend AMR

A

Clinically Reportable Range (CRR)

69
Q

Type of systematic error in the sample
direction and magnitude; the magnitude of
change is constant and not dependent on the
amount of analyte

A

Constant Error

70
Q

Effect of a compound/s on the accuracy of the
detection of a particular analyte

A

Interference

71
Q

Substances that cause interference

A

Interferents

72
Q

Lowest amount of analyte accurately detected
by a method

A

Limit of Detection

73
Q

Lowest amount of analyte that can be
reported while achieving a precision target
(e.g. lowest concentration at which a CV of 10% may be achieved)

A

Limit of Quantitation

74
Q

Body component (e.g. fluid and urine) in which
the analyte is to be measured

A

Matrix

75
Q

Dispersion of repeated measurements about
the mean due to analytic error

A

Precision

76
Q

Type of systematic error where the magnitude
changes as a percent of the analyte present,
error dependent on analyte concentrations

A

Proportional Error

77
Q

➔ Error varies from sample to sample
➔ Causes include instrument instability,
temperature variations, reagent variation,
handling techniques, and operator variables

A

Random Error

78
Q

➔ Ability of an analytic test to measure a known amount of analyte
◆ A known amount of analyte is added
to real sample matrices

A

Recovery

79
Q
A
80
Q

➔ Refers to the difference between the
measured value and the mean expressed as a
number of SDs
➔ An SDI = 0: value is accurate or in 100%
agreement
➔ An SDI = 3: 3 SDs away from the target (mean) and indicates inaccuracy
➔ SDI may be positive or negative

A

Standard Deviation Index

81
Q
A
82
Q

Error always in one direction (may be constant or proportional

A

Systematic Error

83
Q

Random error + Systematic error

A

Total Error

CLINICAL CHEMISTRY 1 (12 decks)

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